Statistical Leader

Senior Statistical LeadWe are seeking an experienced and skilled Senior Statistical Lead to join our team. As a key member of our clinical development programs, you will work closely with cross-functional teams to deliver high-quality statistical results.This is an exciting opportunity to contribute your expertise in statistical programming, data analysis, and project management to drive successful outcomes in pharmaceutical development. You will have the autonomy to work independently and collaboratively, leveraging your technical skills and business acumen to achieve program goals.Key Responsibilities:Lead statistical programming efforts for multiple clinical studies, overseeing CRO vendors and ensuring timely delivery of high-quality results.Develop and implement complex statistical analyses, datasets, and reports, working closely with Statisticians and other stakeholders.Maintain and improve existing SAS and R programming standards, tools, and macros, contributing to the creation of new ones as needed.Collaborate with internal and external partners to develop CRFs, edit check specifications, and data validation plans.Provide expert guidance on FDA regulations affecting clinical trial data reporting, ensuring compliance and adherence to good clinical practice.Requirements:Proven experience as a senior statistical programmer or lead, with a strong track record of delivering high-quality results.Expertise in statistical programming languages (SAS, R), data analysis, and project management.Familiarity with FDA regulations, good clinical practice, and electronic submissions guidelines.Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.Candidates should possess a bachelor's degree in a quantitative field (Statistics, Mathematics, Computer Science) or equivalent experience. Advanced degrees are a plus.